FDA Adverse Event
Malfunction
Summary report: N
INFUSION PUMP
MDR report key: 3122573
·
Received May 21, 2013
Report
- Report Number
- 3007566237-2013-01694
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Report Date
- March 7, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID 8703W, LOT# L80990, PRODUCT TYPE CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
REPORTEDLY THE EMPTY PUMP HAD BEEN ASSOCIATED WITH SCHEDULING THE REFILL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT¿S PUMP HAD GONE DRY. IT WAS STATED THAT THE PATIENT WITHDRAWAL SYMPTOMS OF TEMPERATURE CHANGES, SWEATING, AND CHILLING. AT THE TIME OF REPORT, THE PUMP CONTAINED DILAUDID, CLONIDINE, AND BUPIVACAINE; HOWEVER, IT WAS UNCLEAR IF THESE WERE STILL IN USE AT THE TIME OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 225082 | INFUSION PUMP | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |